CN103260559B - There is the infusion sleeve of multiple material layer - Google Patents

There is the infusion sleeve of multiple material layer Download PDF

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Publication number
CN103260559B
CN103260559B CN201180060018.5A CN201180060018A CN103260559B CN 103260559 B CN103260559 B CN 103260559B CN 201180060018 A CN201180060018 A CN 201180060018A CN 103260559 B CN103260559 B CN 103260559B
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China
Prior art keywords
phacoemulsification
infusion sleeve
main part
internal layer
infusion
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Expired - Fee Related
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CN201180060018.5A
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Chinese (zh)
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CN103260559A (en
Inventor
G·C·廖
K·T·洪
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Alcon Research LLC
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Alcon Manufacturing Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • A61F9/00736Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
    • A61F9/00745Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments using mechanical vibrations, e.g. ultrasonic

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Surgical Instruments (AREA)

Abstract

Disclose a kind of phacoemulsification systems.This system comprises phacoemulsification handpiece and the dismountable infusion sleeve of selectivity.Infusion sleeve can comprise single main part, and this single main part is limited by the first open end and the second open end and has hollow interior portion wherein.Main part can comprise and has at least one internal layer and at least one outer field multiple layer, make layer by independently with different material structures.

Description

There is the infusion sleeve of multiple material layer
Priority request
This application claims that December in 2010 15 days is that submit to, name is called " infusion sleeve with multiple material layer ", serial number is 61/423, the priority of the U.S. Provisional Patent Application of 183, the inventor of above-mentioned application is GraceChuangLiao and KarenT.Hong, above-mentioned application is intactly incorporated in this by reference, as carried out all sidedly and intactly in this article describing.
Technical field
The disclosure relates generally to the field of phacoemulsification, and relates more specifically to the field of infusion sleeve.
Background technology
Typical phacoemulsification ultrasonic surgical devices is made up of attached cutting tip and the ultrasound-driven head and electronic control module pouring into sleeve (being also referred to as infusion sleeve).Head comprises fill up line, aspiration line and electric wire substantially, and all these are interconnected to control module substantially and are controlled by control module.In use, cutting tip and attached infusion sleeve are inserted in the minimal incision * in cornea or other position.Power level in control module change head, with supersonic vibration cutting tip, provides the perfusion between infusion sleeve and cutting tip simultaneously.Control module also provides vacuum by the aperture in cutting tip.
Except cutting tip, infusion sleeve is the unique portion contacted with patient.Therefore, the operability of infusion sleeve is of crucial importance for the overall performance of phacoemulsification equipment.A focus in phacoemulsification surgical procedure is the problem of the heat accumulation in cutting tip.Wound pressure compress wall on infusion sleeve wall and cause to and from cutting tip reduction fluid flowing and vibration cutting tip and the wall of infusion sleeve between heat-dissipating CONTACT WITH FRICTION.Therefore, when cooling fluid flowing reduces, frictional heat increases and the means of the heat that do not dissipate.Heat accumulation can cause sclera or Corneal Burn soon.When using higher frequency (that is, more high-energy) to vibrate, this problem becomes more and more concerned.Passively, Corneal Burn can be alleviated by surgeon by the suitable adjustment of the combination of operating parameter (size of ultrasonic emulsification power of such as carrying and the volume of irrigation/aspiration flow).In addition, the nose assembly (or probe) of some prior aries mostly just depends on the flowing of veining sleeve lining and the infusion liquid between cutting tip and sleeve and is drawn in cutting tip lumen pore to cool the flowing of the material of cutting tip.But during exemplary lens emulsification procedure, the viscoelastic material opposing infusion liquid be expelled in eyes anterior chamber flows out sleeve and has high-drag for the suction flowing entered in cutting tip lumen pore.So when cutting tip contacts with viscoelastic material with sleeve, suction and perfusion of fluid flow into and flow out eyes and can temporarily get clogged.This temporary block can cause cutting tip overheated and consequent sclera and/or corneal injury suddenly.Therefore, there is (in 1 to 3 second) soon, even if therefore very short time is exposed to so overheated ocular tissue that also can cause damaging delicate because cutting tip is overheated.
Attempt to prevent the method for other prior art of heat trnasfer from being utilized by the use of " Mackool is most advanced and sophisticated ".Mackool tip is two-part infusion sleeve, have insert in toughness outer sleeve and by toughness outer sleeve around rigidity inner sleeve.Rigidity inner sleeve is considered to the part at Mackool ultrasonic emulsification tip and is positioned at loosely in the main shaft portion at Mackool ultrasonic emulsification tip.The object of rigidity inner sleeve makes vibration syringe needle depart from infusion sleeve.Comprise rigidity inner sleeve and cause more sharply reducing of heat.
Although proved that Mackool is most advanced and sophisticated effective in the hot generation of reduction, still there is the space of improvement.Particularly, need a kind of infusion sleeve, it eliminates the use of independent rigidity inner sleeve, still provides additional heat to reduce character simultaneously, has the reduction friction in single-piece infusion sleeve.
Summary of the invention
Disclose a kind of phacoemulsification systems.This system comprise phacoemulsification handpiece and can selectivity dismounting infusion sleeve.Infusion sleeve can comprise single main part, and this single main part is limited by the first open end and the second open end and has hollow interior portion wherein.Main part can comprise and has at least one internal layer and at least one outer field multiple layer, make layer by independently with different material structures.
Accompanying drawing explanation
By example, exemplary embodiment of the present disclosure is described referring now to accompanying drawing in more detail, wherein:
Fig. 1 is the perspective view of exemplary phacoemulsification handpiece assembly;
Fig. 2 is the enlarged perspective of the exemplary multiple layer infusion sleeve engaged with the phacoemulsification handpiece of Fig. 1;
Fig. 3 is the perspective cut-away schematic view of the exemplary multiple layer infusion sleeve of Fig. 2, and the interior zone of infusion sleeve is shown; And
Fig. 4 is the magnification fluoroscopy sectional view of the exemplary multiple layer infusion sleeve of Fig. 3, and multiple layers of infusion sleeve are shown.
Fig. 5 is the amplification view of a part for the high-crowned exemplary multiple layer infusion sleeve of liter had for reducing friction element.
Fig. 6 is the amplification view of a part for the exemplary multiple layer infusion sleeve of the depression valley had for reducing friction element.
Fig. 7 is the amplification view of a part for the exemplary multiple layer infusion sleeve of the low-friction coating had for reducing friction element.
Detailed description of the invention
With reference now to following discussion, and also with reference to accompanying drawing, show in more detail the exemplary arrangement of disclosed apparatus and method.Although accompanying drawing represents some possible schemes, accompanying drawing may not draw in proportion and some feature can amplify, remove or partly cutting to illustrate better and to explain the disclosure.The description carried out herein is in addition not intended at large or claim is limited in another manner or be limited to display in the accompanying drawings and disclosed concrete form and configuration in the following detailed description.
With reference to Fig. 1 and 2, exemplary Phacoemulsification device 10 is shown.Phacoemulsification device 10 is limited by far-end 12 and near-end 14, and hollow machine head main body part 16 betwixt.Main part 16 can interconnect (showing best in fig. 2) rotatably at far-end 12 and perfusion infusion sleeve 50.Main part 16 can be included in the inner proximally 14 ultrasound-driven inner sleeves 20 extending to the integrated cutting tip 22 at far-end 12 place substantially.Inner sleeve 20 can be communicated with through the cataract tissue of emulsifying or the aspiration line 32 of aspirated liquid with for removing with the electric wire 30 of the power of the supersonic vibration of control cutting tip 22.In addition, fill up line 34 can be fluidly connected to pipe 56, and the hollow region 60(that described pipe has between the inner surface 62 and the outer surface of sleeve pipe 20 of infusion sleeve 50 sees in figures 3 and 4 best).
Can see in fig 1 and 2, infusion sleeve 50 directly can be fixed to the far-end 12 of the main part 16 of Phacoemulsification device 10.Infusion sleeve 50 can comprise the main body or the basic portion section 52 that extend to cone-shaped nose portion section 54 from the connecting portion of the far-end 12 of main part 16 substantially, and described cone-shaped nose portion section tapers to elongate tube portion section 56 downwards from basic portion section 52.Infusion sleeve 50 is included in the inner hollow region 60 extending to cone point 58 from basic portion section 52 substantially.Cone point 58 can comprise the one or more fluid orifices 70 fluidly connecting the otch in interior hollow region 60 and pupil region.In addition, infusion sleeve 50 also can comprise the projection 66(extended from the outer surface 64 of the infusion sleeve 50 of cone-shaped nose portion section 54 or basic portion section 52 and sees best in fig. 2).Projection 66 can be provided for the rigidity and the increase grasping that operate Phacoemulsification device 10.
See Fig. 3 and 4, exemplary infusion sleeve 50 is shown in cross-section.As shown in the figure, infusion sleeve 50 comprises the screw thread 68 for infusion sleeve 50 being connected to rotatably main part 16.But, other Connection Element can be used, such as but not limited to tab and groove arrangement, sun and cloudy latching ledge, twistlock sun lug and corresponding cloudy accepter (that is, luer is arranged) and provide other well known elements be tightly connected between infusion sleeve 50 and main part 16.With further reference to Fig. 3, can see that interior hollow region 60 is from threaded portion 68 transition and the cone point 58 tapered to residing for fluid orifice 70 downwards.Particularly, as mentioned above, fluid orifice 70 can be located around the neighboring of cone point 58.Fluid orifice 70 can depend on that application has any size and any shape.As shown in the figure, fluid orifice 70 is the circular holes being positioned at relative both sides.
As shown in Figures 3 and 4 and as mentioned above, infusion sleeve 50 comprises outer surface layer 64 and interior surface layers 62.In exemplary arrangement, outer surface layer 64 extends and can with the minimized material manufacture providing heat and Motion Transmission in the length of infusion sleeve 50.Generally speaking, the material of such outer surface layer 64 can include but not limited to silicones, polyimides, polyethylene and acetal.Often kind of material can have specific Equivalent Hardness scope (following), has the total heat conductivity in the scope of 0.1-0.9W/ (m* ° of K).Particularly, silicones can have the hardness in the scope of 30-80 Shore A, polyimides can have the hardness in the scope of 65-92 Shore D, and polyethylene can have the hardness in the scope of 45-53 Shore D and acetal can have the hardness in the scope of 70-88 Shore D.But with which kind of material of use have nothing to do, the hardness of cladding material is by the hardness lower than inner layer material, and reason is that internal layer is larger than outer rigidity.Particularly, outer surface layer 64 may be used for minimizing the heat and Motion Transmission that can be transferred to cornea, and this can contribute to the probability reducing Corneal Burn and mechanical trauma during phacoemulsification surgery program.The more soft material used also can provide the better sealing around otch, reduces contingent any otch thus and leaks.
In addition, interior surface layers 62 can with the material manufacture provided compared with crust, and described material can have and makes to minimize the mantle friction of vibration cutting tip 22 compared with low-friction coefficient.Generally speaking, the material of such interior surface layers 62 can include but not limited to injection moldable polyimides and acetal.These materials typically can have large friction co-efficient value in the scope of 0.1 to 0.3.Interior surface layers 62 also can comprise mechanical features, such as but not limited to protuberance 80(see Fig. 5), the valley 82(of rib, ridge, depression is see Fig. 6) or cause other the such reduction friction element of the random interruption in interior surface layers 62.Mechanical features can be combined with the specific manufactured materials of the material being different from outer surface 64.In addition, interior surface layers 62 can comprise (independently or reduce friction element with one or more other combine) as reducing the low-friction coating 84(of friction element see Fig. 7).Coating can be but be not limited to Parylene (parylene) N or other type Parylene coating and or there is other known fluoropolymer coating of large coefficient of friction in the scope of 0.1 to 0.3 LSR(OrionIndustries).Depend on application, layer material, mechanical features and coating can use simultaneously or all can use individually.In certain embodiments, use at least two different layers, and inner layer material is larger than cladding material rigidity.
Compare with the design of previous more than one piece with previous single design of material, multiple layer may be used for providing additional heat and friction to reduce character simultaneously.In an exemplary arrangement, multi-player injection molding or molded technique can be used to produce two layers 62,64.As just example, multicomponent, multiple and molded technique may be used in unitary construction, produce multilamellar infusion sleeve.
Multicomponent molding can also be subdivided into common injection, double injection and interval injection.Sequentially be expelled in same mould as crust with a kind of material as core body with a kind of material injection-molded comprising altogether.It is also referred to as insert molding, and reason is that core body is completely encapsulated.Double injection molding is different materials injection pass through different cast gate while.Interval is injection-molded is also referred to as marble pattern, is to inject while different materials passes through to provide the different cast gates of finite mixtures.
Multiple molding describes the injection of application different materials with any technique producing final parts.This comprises and transmits molding, injection-molded, core post moulding and throw molding.Wherein multiple matter blocks of different materials can be expelled in mould to produce multi-layered product.
Molded comprises embedding molding and losing core moulds, and the latter produces hollow part.Molded allow expect parts preform and and then the extra play embedded for the material by being applied to primitive part in mould.
In use, infusion sleeve screw thread 68 can engage two pieces to be locked as a unit rotatably with the respective threaded of main part 16.Further assembling comprises aspiration line 32, fill up line 34 and electric wire 30 is attached to control module to form phacoemulsification assembly.Should know that infusion sleeve 50 can have various diameter and length to adapt to specific phacoemulsification cannula 20 and main part 16.The selection of infusion sleeve 50 can comprise selects sleeve to extend preset distance to allow to extend beyond the suitable aligning of the cutting tip 22 of fluid orifice 70 to allow cutting tip 22 from the end of infusion sleeve 50.This can allow cutting tip 22 to provide enough supersonic vibration to smash or emulsifying cataract and the additional liquid only aspirating cataract tissue and do not aspirate from otch.This preset distance also can contribute to preventing from the directly any infusion liquid of suction of the hollow region 60 in infusion sleeve 50.
Once generation component, operator can start control module to cause Phacoemulsification device sleeve pipe 20 supersonic vibration, and these vibrations are transmitted along cutting tip 22, be used for smashing or emulsifying cataract or other ultrasonic emulsification type tissue in the vibration of described cutting tip place.Vacuum source can be started to be illustrated in fig 1 and 2 by sleeve pipe 20() in central lumen 24 aspirate tissue through emulsifying or aspirated liquid, described central lumen starts at cutting tip 22 place and extends to flexible aspiration line 32 by main part 16, and described flexible aspiration line extends to control module.Irrigation source supplies infusion liquid (such as saline solution) under stress by fill up line 34, described fill up line extends to the hollow region 60 in infusion sleeve 50 along main part 16, force infusion liquid to be moved between pipe 56 and sleeve pipe 20 along the interior surface layers 62 of pipe 56 in described hollow region.The size of pipe 56 is determined to be and coordinates safely around sleeve pipe 20, and this allows infusion liquid to leave infusion sleeve 50 to provide the lubrication of incision tract by fluid orifice 70.
As mentioned above, the interaction between infusion sleeve 50 and sleeve pipe 20 can cause overheated and nuisance vibration.So exemplary infusion sleeve 50 can be configured with additional layer of material 72, as shown in Figure 4.Extra play 72 can provide additional and reduce frictional property, additional refractory character or their combination, as above about producing as described in the material that uses in multilamellar infusion sleeve 50.These additional requirements can be depended on predetermined and expect application.Should know when using mechanical organ, the amount of the CONTACT WITH FRICTION area between sleeve pipe 20 and inner surface 62 can reduce/minimize to reduce the frictional heat produced by vibration.In addition, when using mechanical organ, can due to Material selec-tion or by the depressed part that infusion liquid remained on element to supply a small amount of infusion liquid (even if the main flow of infusion liquid is interrupted) continuously, soak sleeve pipe 20 continuously by lubrication infusion liquid thus and final immersion cutting tip 22, thus keep additional lubricity.
Have a wide range of applications understanding described apparatus and method herein.Select and describe the principle and some practical applications that previous embodiment is illustratively method and apparatus.Description above can make those skilled in the art in various embodiments and to be suitable for the various amendment using method of special-purpose of expecting and device.According to the regulation of patent statute, explain in the exemplary embodiment and illustrate principle of the present disclosure and operator scheme.
The scope of this method and device is intended to be limited by following claim.But, it must be understood that exemplary embodiment can be implemented to be different from specific explanations and illustrational mode and not depart from its spirit or scope.The spirit and scope that the various alternatives of the embodiment described in those skilled in the art is to be understood that herein may be used for implementing the claims and do not depart from as limited in following claim.The scope of the present disclosure should not determined with reference to above description, but the full breadth that should change into reference to the equivalent of subsidiary claim and such claim is determined.Can to predict and desirably future development will occur in herein described field, and disclosed system and method will be comprised in such future examples.In addition, all terms used in the claims are intended to have reasonable dismissal and their the usual implication of those skilled in the art understands their most broad sense, unless carried out contrary clearly instruction in this article.Especially, the use of singular article (such as " ", " being somebody's turn to do ", " described " etc.) is to be understood as the key element describing one or more instruction, except non-claimed carries out contrary clearly restriction.Following claim is intended to limit the scope of the present disclosure and therefore method and apparatus in the scope of these claim and equivalent thereof is contained.In a word, be to be understood that exemplary embodiment can modify and change and only be limited by following claim.

Claims (19)

1. a Phacoemulsification infusion sleeve, comprising:
Main part, described main part is limited by the first open end and the second open end, described first open end is at the cone point place of the far-end of described main part, described second open end is at the opposite end place of described main part and for being connected with Phacoemulsification device, wherein, described main part has hollow interior portion wherein, and this hollow interior portion extends between the first open end and the second open end; And
Wherein said main part comprises at least one outer and at least one internal layer, at least one skin described and at least one internal layer extend from the cone point of the far-end of described main part, at least one skin described is molded and forms integrated part together with at least one internal layer, wherein this at least one skin is by the first material structure, this at least one internal layer is by the second material structure, and the rigidity of described second material is larger than the rigidity of described first material;
At least one internal layer wherein said comprises at least one and reduces friction element.
2. Phacoemulsification infusion sleeve according to claim 1, wherein at least one extra play is between described internal layer and described skin.
3. Phacoemulsification infusion sleeve according to claim 2, the hardness range of wherein said first material is at least one in 30-50 Shore A and 50-80 Shore D.
4. Phacoemulsification infusion sleeve according to claim 1, at least one reduction friction element wherein said comprises the valley of at least one ridge or at least one depression.
5. Phacoemulsification infusion sleeve according to claim 1, at least one reduction friction element wherein said is low-friction coating.
6. Phacoemulsification infusion sleeve according to claim 5, wherein said low-friction coating is at least one in Parylene coating and fluoropolymer coating.
7. Phacoemulsification infusion sleeve according to claim 1, wherein said second material has the friction co-efficient value in the scope of 0.1 to 0.3.
8. Phacoemulsification infusion sleeve according to claim 1, wherein said second material is biocompatible material and is constructed by the one in polyimides and acetal.
9. Phacoemulsification infusion sleeve according to claim 1, the hardness range of wherein said first material is at least one in 30-80 Shore A and 45-92 Shore D.
10. Phacoemulsification infusion sleeve according to claim 1, wherein said first material has the total heat conductivity in the scope of 0.1-0.9W/ (m* ° of K).
11. Phacoemulsification infusion sleeve according to claim 1, wherein said first material is biocompatible material and is minimized to make at least one in heat trnasfer and Motion Transmission by a kind of structure in silicones, polyimides, polyethylene and acetal.
12. Phacoemulsification infusion sleeve according to claim 2, at least one extra play wherein said is by having the material structure that heat minimizes character, Motion Transmission minimizes character and rub at least one reduced in character.
13. Phacoemulsification infusion sleeve according to claim 2, at least one extra play wherein said is biocompatible material and is constructed by the one in silicones, polyimides, polyethylene and acetal.
14. 1 kinds of phacoemulsification handpieces, comprising:
Crosshead body, wherein said crosshead body comprises the sleeve pipe be longitudinally positioned in described crosshead body;
Multiple field single-piece infusion sleeve, wherein said infusion sleeve is limited by main part, described main part comprises the internal layer with the first material, the skin with the second material, the first open end being connected to described crosshead body and second open end of locating around described sleeve pipe, wherein said infusion sleeve has hollow interior portion wherein, and wherein said infusion sleeve is single parts by described first material and described second material structure, the hardness of wherein said first material is greater than the hardness of described second material;
Wherein, described skin and internal layer extend from the cone point of the far-end of described main part, and described skin is molded and forms integrated part together with internal layer;
Wherein said internal layer comprises at least one and reduces friction element.
15. phacoemulsification handpieces according to claim 14, wherein said internal layer, described skin and at least one in being positioned between described internal layer and described skin extra play are constructed by the one in silicones, polyimides, polyethylene and acetal.
16. phacoemulsification handpieces according to claim 15, at least one wherein in cladding material and extra play material has makes heat and the minimized performance of Motion Transmission and at least one in 30-50 Shore A and 50-80 Shore D of hardness range.
17. phacoemulsification handpieces according to claim 16, wherein said reduction friction element is at least one in the valley of projection and the depression raised.
18. phacoemulsification handpieces according to claim 15, wherein said reduction friction element is low-friction coating.
19. phacoemulsification handpieces according to claim 14, the hardness range of wherein said cladding material is at least one in 30-80 Shore A and 45-92 Shore D, and wherein said cladding material has the total heat conductivity in the scope of 0.1-0.9W/ (m* ° of K).
CN201180060018.5A 2010-12-15 2011-12-05 There is the infusion sleeve of multiple material layer Expired - Fee Related CN103260559B (en)

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US42318310P 2010-12-15 2010-12-15
US61/423,183 2010-12-15
PCT/US2011/063242 WO2012082425A2 (en) 2010-12-15 2011-12-05 Infusion sleeve with multiple material layers

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CN103260559B true CN103260559B (en) 2016-01-06

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EP2651486A2 (en) 2013-10-23
EP2651486B1 (en) 2016-04-13
CA2817762A1 (en) 2012-06-21
WO2012082425A3 (en) 2013-07-18
JP2014505514A (en) 2014-03-06
ES2585399T3 (en) 2016-10-05
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EP2651486A4 (en) 2014-06-11
CN103260559A (en) 2013-08-21
AU2011341430A1 (en) 2013-06-06
WO2012082425A2 (en) 2012-06-21
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US20120157934A1 (en) 2012-06-21
AU2011341430B2 (en) 2016-06-30

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